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Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation (LIPID-AF)

7 de agosto de 2026 atualizado por: She JianQing, First Affiliated Hospital Xi'an Jiaotong University

Association of Peripheral Blood Lipidomic and Ceramide Profiles With Atrial Fibrillation: A Prospective Multi-Cohort Observational Study

This prospective multi-cohort observational study evaluates the association between peripheral blood lipidomic and ceramide profiles and atrial fibrillation. The study hypothesis is that peripheral blood lipidomic features and ceramide-related profiles are associated with the presence of atrial fibrillation. Participants with atrial fibrillation and control participants with other cardiovascular diseases will be prospectively enrolled. Peripheral blood samples will be analyzed using untargeted lipidomic profiling in one cohort and targeted ceramide assays in another cohort.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Atrial fibrillation is a common cardiac arrhythmia associated with metabolic disturbance and cardiac remodeling. Lipid metabolism, including sphingolipid and ceramide metabolism, may be involved in the pathophysiology of atrial fibrillation. Further clinical evidence is needed to clarify whether peripheral blood lipidomic and ceramide profiles are associated with atrial fibrillation.

This study is designed as a prospective multi-cohort observational study. Participants will be classified into an atrial fibrillation group or a control group according to Holter monitoring and clinical information. Control participants will be patients with other cardiovascular diseases without documented atrial fibrillation. Peripheral blood samples will be collected for lipidomic or targeted ceramide analysis.

Untargeted lipidomic profiling will be used to evaluate peripheral blood lipidomic features in one cohort, and targeted ceramide assays will be used to evaluate peripheral blood ceramide profiles in another cohort. The overall purpose of this study is to explore the relationship between peripheral blood lipidomic and ceramide profiles and atrial fibrillation.

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recrutamento
        • First Affiliated Hospital of Xian JiaotongUniversity
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population includes adult patients prospectively enrolled from clinical cardiovascular cohorts. Participants will include patients with atrial fibrillation diagnosed by Holter monitoring and control patients with other cardiovascular diseases without documented atrial fibrillation. All participants will provide peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

Descrição

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Participants who are able to provide informed consent.
  • Participants diagnosed with atrial fibrillation based on Holter monitoring, or control participants with other cardiovascular diseases and no documented atrial fibrillation.
  • Participants with available peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent.
  • Missing key clinical information.
  • Missing or poor-quality peripheral blood samples unsuitable for lipidomic or targeted ceramide analysis.
  • Participants considered unsuitable for this study by the investigators.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Cohort 1 Atrial Fibrillation Group
Participants in cohort 1 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.
Outro: Peripheral blood untargeted lipidomic profiling
Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.
Cohort 1 Control Group
Control participants in cohort 1 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using untargeted lipidomic profiling.
Outro: Peripheral blood untargeted lipidomic profiling
Peripheral blood samples from cohort 1 will be analyzed using untargeted lipidomic profiling. No treatment or therapeutic intervention will be assigned by the investigators.
Cohort 2 Atrial Fibrillation Group
Participants in cohort 2 diagnosed with atrial fibrillation based on Holter monitoring. Peripheral blood samples will be analyzed using targeted ceramide assays.
Outro: Peripheral blood targeted ceramide assay
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.
Cohort 2 Control Group
Control participants in cohort 2 with other cardiovascular diseases and no documented atrial fibrillation. Peripheral blood samples will be analyzed using targeted ceramide assays.
Outro: Peripheral blood targeted ceramide assay
Peripheral blood samples from cohort 2 will be analyzed using targeted ceramide assays. No treatment or therapeutic intervention will be assigned by the investigators.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peripheral Serum Concentration of Cer(d18:1/18:1), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/18:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Peripheral Serum Concentration of Cer(d18:1/16:0), nmol/L
Prazo: baseline
The concentration of Cer(d18:1/16:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
baseline
Peripheral Serum Concentration of Cer(d18:1/18:0), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/18:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Peripheral Serum Concentration of Cer(d18:1/20:0), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/20:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Peripheral Serum Concentration of Cer(d18:1/22:0), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/22:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Peripheral Serum Concentration of Cer(d18:1/24:0), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/24:0) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Peripheral Serum Concentration of Cer(d18:1/24:1), nmol/L
Prazo: Baseline
The concentration of Cer(d18:1/24:1) in peripheral serum will be quantified using a targeted mass spectrometry-based assay and reported in nmol/L. Concentrations will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/18:1), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/18:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/16:0), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/16:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/18:0), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/18:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/20:0), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/20:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/22:0), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/22:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/24:0), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/24:0) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline
Normalized Relative Abundance of Serum Cer(d18:1/24:1), AU
Prazo: Baseline
The normalized relative abundance of Cer(d18:1/24:1) in peripheral serum will be measured using an untargeted mass spectrometry-based lipidomics platform and reported in arbitrary units (AU). Relative abundance will be compared between participants with atrial fibrillation and control participants.
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

First Affiliated Hospital Xi'an Jiaotong University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de junho de 2017

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de agosto de 2026

Primeira postagem (Real)

11 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • XJTU1AF-CRF-2018-025

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared because the study involves clinical information and biological sample-related data. Data sharing is not planned beyond the approved study protocol and ethical approval.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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